Segena

Segena offers services of Regulatory and Government Affairs to companies producing medicines for human use (medicinal products, generic drugs, drugs based on vegetable extracts, SOP and OTC), veterinary medicines, products for special diets (dietetic products, supplements, herbal medicines), cosmetics, medical devices, medical and surgical aids, biocides, homeopathic and diagnostic products).

It uses a quality management system that complies with the requirements of the ISO 9001:2000 certification.

Segena offers its clients:

• professional competence and reliability, guaranteed by the application of well-established know-how on the part of a highly experienced staff possessing a profound knowledge of regulatory contexts and the ability to forestall their evolutions;
• the ability to meet clients' priorities and deadlines, through an efficient and flexible organization;
• customer satisfaction monitoring;
• process and performance indicator monitoring connected to the clients' goals;
• improvement of internal procedures also through the consolidation of methods and technological innovation;
• ongoing training, development of team skills and the application of appropriate partnering programs for new staff.

Segena has obtained a QUALITY CERTIFICATION for the following services:

Outsourcing management of the administrative tasks with governmental institutions. A system of outsourcing management of the company´s administrative procedures with governmental institution that is implemented for the whole life cycle of the product.

Technical and regulatory activities A specialized organization for the activity of technical consulting aimed to the production of documents related to the entire life cycle of the product.

Regulatory monitoring and public relations support An accurate system for regulatory monitoring and support to the clients´ public relations.